A general thread on the PACE trial!

The CEO of AFME at the time (Chris Clarke) sold PACE to the members as a study on pacing. I'm sure AFME did one of their endless polls, that one asked what the members wanted research on. Many members wanted research on pacing. When the content of the PACE Trial was questioned, that it was a study on CBT and GET, Chris Clarke said that was the only way they could get a study on pacing. AFME ran an article in their magazine 'Interaction' (2002/3/4?) that said (I paraphrase) 'Hooray Hooray, we have a study on pacing'. I have the Interaction copy somewhere or other in the chaos of my flat.

 

Early criticism of PACE included that it used the Oxford Criteria for participant selection.

 

Here's one of those surveys, published in the October 2002 edition of InterAction (issue 42), after the Medical Research Council asked for research priorities from patient organisations, following the CFS/ME Working Group report to the CMO published in Jan 2002:



What patients got was PACE.

 

Interesting how AfME interpreted that table, especially the fifth bullet point:


It looks, to me, like (some at) AfME had their own priorities.

 

Actually, they weren't...
after PACE was released, one of the authors (pretty sure it was Sharpe but it could have been White) on twitter said that PACE was a study into CFS only & results could not be extrapolated for ME .

I dont have a link but i am certain thats the case as much was made of it at the time & i can 'see' the tweet in my mind's eye. I didnt save it as i knew it was irrelevant bandying of words, but they definitely did say that, or words to that effect, i dont have energy to look but i'd bet theres in image of it here on S4 somewhere

 

See: https://www.s4me.info/threads/who-hijacked-me.28199/

At the moment patients who experience damage from exercise don't have an accurate diagnosis, they are illness misfits. It's what my currant signature means, ME to medical professionals does not mean (and never meant) damage from exercise.

 

But in real life it's more complicated than that. It's almost impossible to work this out in criteria, but many of us, like me, did not have chronic fatigue for many months or years while we had PEM and many of the other symptoms. There was fatigue, sure, but it was a distant and relatively ignorable thing.

I've seen many with LC report the same. For months they didn't have any of that crushing fatigue. They had some, but they would report no to having chronic fatigue, it just didn't describe their problem well. And then it hit. It creates all sorts of problems when seen in a broader perspective. For example I had what I would properly consider mild chronic fatigue in my teens. Only fatigue, nothing else, and it was possible to push through, I had a mostly normal life with plenty of sports and activities, although sometimes I'd sleep 12-15h per day. It had nothing to do whatsoever with the illness I later developed and have had for 16 years.

So by usual criteria and definition alone, shmaybe, but really it's a lot more complicated than that, and ME, CFS or ME/CFS, however it's defined, can't be contained fully within a chronic fatigue umbrella. It's a big overlap, but from such a high-level definition, MS overlaps almost as strongly. That's the problem with common non-specific symptoms, they're basically found in almost all illnesses to a varying degree.

Of course that discussion is basically impossible for the most part, very few people are aware of this, and even fewer would think it makes sense, especially with having made everything about fatigue, and then with the odd decision that fatigue is mostly psychiatric, which makes zero sense. But making sense isn't high on the list of priorities for natural phenomena. What matters for a theoretical model that explains the whole is to make sense of the data, however little sense they seem to make. And from that the intersection is a lot more complicated than a simple general set and subset.

 

They're happy to let everybody conflate the two concepts. I've never seen them mention in their research the harm of conflating ME with idiopathic chronic fatigue. Sharpe said in the intro of the PACE trial that some researchers think ME and CFS are separate illnesses.

 

yes DD i know that, of course they are happy to let people conflate the 2!.... except when it suits them not to.
And in this case, when they were trying to play semantics & weedle out of things, either he or White did say that (or words to that effect, on twitter, because i remember it being shouted about a lot at the time, its a lot of yrs ago now.

I wont press the point further, because without an image of the tweet in question, i cant prove it, but it was defintiely said. But he wasnt saying it in any way that would have been helpful for us.

 

Wow, you can see where their move towards 'fatigue' being their big thing they realised they could 'own' and make as lowest common denominator / black box as possible over the years as a 'school' basing its papers on manifestos and a focus on lobbying to ever weaken methodology 'robustness' (if there is anything left by now) developed from.

The Crawley et al (2013) paper which included White and took place in clinics around the same time as PACE basically found that there was no effect on physical function, but could eke some claim short-term from the CFQ with a recommendation that the answer is 'new PROMS' ie change the measures.

And there he is even earlier weasel-wording why he didn't want to 'combine' anything because he knew it didn't work for physical function. But maybe if they separated them they could wangle something out of the most ambiguous subjective fatigue one. And they'd have had some inkling on the objective measures and drop-outs by the sounds I guess too.

SO there was a heck of a lot of research all at the same time from different angles, albeit it was messing with research design to claim effects, all coming up with the same issue - that there really (just as we see nowadays) was nothing even short-term 'of use' coming from any of their 'help' [and at the same time of course they didn't really note drop outs they got to not include, or really have to talk about harms or do yellow cards like drugs or other areas of medicine would].

Basically, if you can exhaust enough really ill people to drop out then you can eke some claim from just 2 points being forced on a subjective chalder fatigue self-report scale as soon as a treatment that effectively hammered participants to 'play down your symptoms, don't whinge, state the positive' and loads of newsletters telling them 'everyone else recovered' was the sum total?

.. and of course whatever you do start dropping anything objective as a measure of disability, even anything subjective that is physical function.

So they must surely have known they were basically brainwashing people into potentially making their actual physical condition and function worse longer term because it did nothing for the underlying condition?

Yes I can see why the only logical positions would be to go from signing off something with a proper method to a huge loss of faith / feeling of it being in bad faith when such intentions start becoming obvious?

 

Does anyone have a copy of this? Or a scan.

ME Association.
MEA calls for PACE trial to be scrapped. ME Essential, July 2004: 91: 3–4

thanks

 

YouTuber and behavioural scientist Pete Judo has done a video debunking the PACE trial. It includes clips with David Tuller and walks through the main problematic aspects with the trial. He also contacts Professor White and gets an answer where White dismisses all critique.

ETA: His descriptions of ME and PEM are not very accurate, but he gets the main aspects with the PACE trial and this video will hopefully bring the story to a wider audience.

 

That was really good. A few issues with PEM being about exercise rather than exertion, but otherwise the tone and content were excellent. Peter White's excuses are just mediocre and look terrible after this exposition of the problems with the study. What a bunch of charlatans.

He speaks very fast so don't forget that Youtube has a function to slow down playback

 

I thought the same. It's already got close to 5,000 views and he just put it up earlier today.

 

https://twitter.com/user/status/1788209660740186178

 

Agreed. And it has just reminded me watching this (I think the last line about CBT, plus the bit about Chalder's misuse/misunderstanding of the term 'normal') that we need to begin requiring that it is underlined that just because Nice NG206 didn't throw out all CBT does NOT mean that it didn't throw out, and underline that included anything along similar lines, CFS-CBT ie anything that was based on the idea of false beliefs or deconditioning being behind ME/CFS.

THAT is being utterly flouted by BACME and what is written in the NHS website currently.

It is one thing saying that if someone wanted to avail themselves of other CBT for other conditions because they had grief or comorbidities then those types of real CBT were 'OK', and another thing twisting that trust imbued on them to use that distinction correctly to take advantage and claim that CBT could address 'symptoms' of the condition and ergo infer it would be a 'treatment'. Which is exactly what I suggest BACME and the King's college lot are trying to do.

SO I do think we need a campaign or pushback to say that needs to be banned. rewording 'false beliefs' to 'caused by being stressed' and still pushing 'think differently' is an outrageous distortion.

And those left who still do proper psychology and use CBT that is designed for the specific issue at hand with real models that work, like eg phobias, should be absolutely outraged and sayign something about these people who have trashed the reputation and usage of that term. They don't have the research behind it that makes it CBT, they just use it like some bang something together based on your beliefs in a day course done by a workplace telling people how they should think.

It isn't anything good for mental health, nevermind 'symptoms'. It is just taking advantage of vulnerable people and funding given that was supposed to go towards real staff who wanted to actually do things they checked would and did actually help. Not the callous disregard we see so prevalent in those who have the pretend 'good intentions' and at the same time utterly refuse to ever look into (or hear about) harms - which means they certainly don't have good intentions other than for themselves as far as I'm concerned.

 

Regarding the Youtube video today explaining the problems with the PACE trial - Trudie Chalder certainly isn't stupid.

Below are snapshots of the timeline I'm just trying to finish from the first part of 2015, just before David Tuller published his first triology of 'Trial by Error' and the whole of 2019. The timeline covers 67 years of this illness.

2015

2019

 

As far as I recall the previous NICE guideline did not recommend GET for severe ME/CFS. My understanding was that was on the basis of the null result for FINE. So in the that sense FINE was useful.

 

Yes, but only because there was no reliable evidence of efficacy – ie no significant improvement in objective measures. If PACE had provided reliable evidence that CBT or GET improved fitness, employment status etc. (which I think many people anticipated) then it would have been relevant to highlight the fact that positive results from a trial of interventions for people with chronic fatigue without PEM do not tell us anything about their efficacy or safely for people with PEM.